Table 1:
Cohort sample characteristics.
| PHASE III | PHASE II/III | |||||||
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| IMRT | PET-BMS-IMRT | All | P | IMRT | PET-BMS-IMRT | All | P | |
| N | 13 | 16 | 29 | 55 | 46 | 101 | ||
| AGE, (MEAN, (SD)) | 53.6 (11.4) | 45.6 (11.4) | 49.2 (11.9) | 0.07 | 54.1 (12.9) | 51.2 (12.1) | 52.8 (12.6) | 0.26 |
| RACE | 0.54 | |||||||
| ASIAN | 0 (0) | 0 (0) | 0 (0) | 11 (20.0) | 7 (15.2) | 18 (17.8) | 0.14 | |
| HISPANIC | 2 (15.4) | 5 (31.2) | 7 (24.1) | 3 (5.5) | 9 (19.6) | 12 (11.9) | ||
| OTHER/MIXED | 2 (15.4) | 3 (18.8) | 5 (17.2) | 3 (5.5) | 4 (8.7) | 7 (6.9) | ||
| WHITE | 9 (69.2) | 8 (50.0) | 17 (58.6) | 38 (69.1) | 26 (56.5) | 64 (63.4) | ||
| BODY MASS INDEX (MEAN (SD)) | 31.6 (9.7) | 32.0 (8.3) | 31.8 (8.8) | 0.91 | 27.8 (7.0) | 29.2 (7.48) | 28.4 (7.2) | 0.34 |
| KARNOFSKY PERFORMANCE STATUS | 0.33 | 0.45 | ||||||
| 70 | 0 (0.0) | 1 (6.2) | 1 (3.4) | 0 (0.0) | 1 (2.2) | 1 (1.0) | ||
| 80 | 2 (15.4) | 0 (0.0) | 2 (6.9) | 4 (7.3) | 1 (2.2) | 5 (5.0) | ||
| 90 | 3 (23.1) | 5 (31.2) | 8 (27.6) | 22 (40.0) | 17 (37.0) | 39 (38.6) | ||
| 100 | 8 (61.5) | 10 (62.5) | 18 (62.1) | 29 (52.7) | 27 (58.7) | 56 (55.4) | ||
| FIGO STAGE | 0.39 | 0.046* | ||||||
| IB1 | 1 (7.7) | 3 (18.8) | 4 (13.8) | 1 (1.8) | 3 (6.5) | 4 (4.0) | ||
| IB2 | 2 (15.4) | 3 (18.8) | 5 (17.2) | 5 (9.1) | 7 (15.2) | 12 (11.9) | ||
| IIA | 2 (15.4) | 0 (0.0) | 2 (6.9) | 3 (5.5) | 1 (2.2) | 4 (4.0) | ||
| IIB | 7 (53.8) | 9 (56.2) | 16 (55.2) | 41 (74.5) | 25 (54.3) | 66 (65.3) | ||
| IIIB | 0 (0.0) | 1 (6.2) | 1 (3.4) | 3 (5.5) | 10 (21.7) | 13 (12.9) | ||
| IVA | 1 (7.7) | 0 (0.0) | 1 (3.4) | 2 (3.6) | 0 (0.0) | 2 (2.0) | ||
| GRADE | 1.00 | 0.52 | ||||||
| 1 | 0 (0) | 0 (0) | 0 (0) | 3 (5.5) | 1 (2.2) | 4 (4.4) | ||
| 2 | 5 (28.5) | 6 (37.5) | 11 (37.9) | 28 (50.1) | 16 (34.8) | 44 (43.6) | ||
| 3 | 6 (54.5) | 7 (53.8) | 13 (44.8) | 18 (32.7) | 16 (34.8) | 34 (33.7) | ||
| UNKNOWN | 2 (15.4) | 3 (18.8) | 5 (17.2) | 6 (10.9) | 13 (28.3) | 19 (18.8) | ||
| TUMOR HISTOLOGY | 0.99 | 0.50 | ||||||
| SQUAMOUS CELL CARCINOMA | 8 (61.5) | 11 (68.8) | 19 (65.5) | 47 (85.5) | 36 (78.3) | 83 (82.2) | ||
| ADENOCARCINOMA | 5 (38.5) | 5 (31.3) | 10 (34.5) | 8 (14.5) | 10 (21.7) | 18 (17.8) | ||
| CHEMOTHERAPY CYCLES RECEIVED | 0.51 | 0.38 | ||||||
| 0 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.8) | 0 (0.0) | 1 (1.0) | ||
| 1 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
| 2 | 1 (7.7) | 0 (0.0) | 1 (3.4) | 3 (5.5) | 0 (0.0) | 3 (3.0) | ||
| 3 | 1 (7.7) | 1 (6.2) | 2 (6.9) | 5 (9.1) | 2 (4.3) | 7 (6.9) | ||
| 4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (5.5) | 4 (8.7) | 7 (6.9) | ||
| 5 | 3 (23.1) | 7 (43.8) | 10 (34.5) | 35 (63.6) | 30 (65.2) | 65 (64.4) | ||
| 6 | 8 (61.5) | 8 (50.0) | 16 (55.2) | 8 (14.5) | 10 (21.7) | 18 (17.8) | ||
| SIB PRESCRIBED | 5 (38.5) | 2 (12.5) | 7 (24.1) | 9 (16.4) | 3 (6.5) | 12 (11.9) | 0.23 | |
| PELVIC BONE MARROW DOSE (%) | ||||||||
| MEAN V10 (SD) | 86.5 (4.4) | 81.5 (6.3) | 83.7 (6.0) | 0.02* | 86.7 (3.3) | 78.9 (6.7) | 78.9 (6.7) | <0.001* |
| MEAN V20 (SD) | 67.3 (7.2) | 60.6 (8.6) | 63.6 (8.6) | 0.03* | 70.0 (4.8) | 56.9 (8.8) | 56.9 (8.8) | <0.001* |
| MEAN V30 (SD) | 39.2 (4.8) | 36.66 (6.6) | 37.8 (5.9) | 0.25 | 43.3 (6.4) | 36.9 (6.2) | 36.9 (6.2) | <0.001* |
| MEAN V40 (SD) | 16.2 (3.8) | 16.2 (7.0) | 16.2 (5.7) | 1.00 | 20.32 (7.0) | 16.7 (5.8) | 16.7 (5.8) | 0.007* |
| MEAN DOSE, GY (SD) | 26.0 (1.7) | 24.6 (2.6) | 25.2 (2.3) | 0.12 | 27.1 (1.6) | 24.0 (2.0) | 24.0 (2.0) | <0.001* |
| MEAN RT DURATION, DAYS (SD) | 52.2 (16.9) | 48.0 (10.4) | 49.9 (13.6) | 0.42 | 48.6 (10.9) | 50.1 (10.3) | 49.3 (10.6) | 0.49 |
Data presented as N(%) unless otherwise specified. SD: standard deviation. IQR: interquartile range. FIGO: International Federation of Gynecology and Obstetrics 2009. IMRT: intensity modulated radiation therapy. PET-BMS-IMRT = positron emission tomography-guided bone marrow sparing IMRT. SIB = simultaneous integrated boost. D95, D97, D99: radiation dose delivered to 95%, 97%, and 99% of the PTV, respectively. V10, V20, V30, V40 = volume receiving 10, 20, 30, 40 Gy, respectively.